NCT03683134

A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.

A Pilot, Theory-Based, Nutrition Intervention Promoting a Mediterranean Diet for the Reduction of Cardiovascular Disease Risk Factors in a High-Risk Population of the Southeastern United States: The Healthy Hearts Program (HHP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Auburn University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.

Conditions

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean diet	Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
DIETARY_SUPPLEMENT	Olive oil and mixed nuts	Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.
BEHAVIORAL	American Heart Association	Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.

Timeline

• Start date: 2017-01-23
• Primary completion: 2017-09-07
• Completion: 2017-09-07
• First posted: 2018-09-25
• Last updated: 2018-09-27

Locations

1 site across 1 country: United States